NCT07806214

Brief Summary

This split mouth study aims to evaluate whether 2 different composite materials used for making clear aligner attachments change color over time and do they have different fluorescent characteristics when illuminated with ultraviolet light. While bonding the attachments, a coin toss will determine which composite resin will be used for upper right segment. The remaining quadrants will be bonded with alternating composite resin. After bonding extraoral photographs under ultraviolet light with cheek retractors will be taken for fluorescence evaluation. Intraoral scans will be performed immediately after bonding and every two months up to six months for evaluating color change.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

September 2, 2026

Last Update Submit

September 2, 2026

Conditions

Composite ResinsClear Aligner Therapy

Keywords

fluorescencecomposite discoloration

Outcome Measures

Primary Outcomes (2)

  • Within-patient difference between composites in ΔE₀₀(color difference)

    Shade codes acquired with scanner software was converted to CIE L\*, a\*, b\* values using the table published by Budde et al(2024). Color change from beginning to 6 months was calculated using CIEDE2000 formula.

    From initial treatment to six months

  • Within-patient difference between materials in fluorescent contrast

    Extraoral photographs under ultraviolet light were analysed in Adobe Photoshop 2020 (Adobe Systems Inc., San Jose, CA, USA). The L\* coordinate was recorded using the colour sampler at the geometric centre of each attachment and at the centre of adjacent unbonded enamel on the same tooth. Fluorescent contrast was defined as ΔL\* = L\*attachment - L\*enamel.

    Baseline

Study Arms (2)

Upper Right Segment GC

EXPERIMENTAL

Patient's upper right segment will be bonded with GC Aligner Connect. Upper left VOCO, lower left GC, lower right VOCO.

Procedure: GC Aligner Connect

Upper Right Segment VOCO

EXPERIMENTAL

Patient's upper right segment will be bonded with VOCO AlignerFlow LC. Upper left GC, lower left VOCO, lower right GC.

Procedure: VOCO AlignerFlow LC

Interventions

GC Aligner ConnectPROCEDURE

Patient's upper right segment will be bonded with GC Aligner Connect. Upper left VOCO, lower left GC, lower right VOCO.

Upper Right Segment GC
VOCO AlignerFlow LCPROCEDURE

Patient's upper right segment will be bonded with VOCO AlignerFlow LC. Upper left GC, lower left VOCO, lower right GC.

Upper Right Segment VOCO

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Receiving Invisalign treatment at the Clinic of the Department of Orthodontics, Faculty of Dentistry, Marmara University
  • Mild to moderate crowding
  • Exhibiting good oral hygiene
  • No active dental caries
  • Voluntarily agreeing to participate in the study and signing the written informed consent form
  • Having no history of any syndrome, systemic disease, or allergy

You may not qualify if:

  • Being pregnant or lactating
  • Presenting with advanced periodontal disease of a severity that could affect orthodontic treatment
  • Having prosthetic restorations within the oral cavity
  • Presenting with white spot lesions prior to orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Faculty of Dentistry Department of Orthodontics

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (3)

  • Ercin O, Kurnaz M, Kopuz D. Evaluation of the color stability of attachments made with different resin composites. Am J Orthod Dentofacial Orthop. 2023 Oct;164(4):e121-e128. doi: 10.1016/j.ajodo.2023.07.008. Epub 2023 Aug 12.

    PMID: 37565944BACKGROUND

  • Budde N, Arnold C, Wienke A, Schweyen R. Comparison of the Clinical Evaluation of Digital Tooth Shade Determination Using an Intraoral Scanner with Proven Subjective and Objective Methods. J Clin Med. 2024 Nov 6;13(22):6668. doi: 10.3390/jcm13226668.

    PMID: 39597813BACKGROUND

  • Albertini P, Tauro R, Barbara L, Albertini E, Lombardo L. Fluorescence-aided removal of orthodontic composites: an in vivo comparative study. Prog Orthod. 2022 May 23;23(1):16. doi: 10.1186/s40510-022-00411-w.

    PMID: 35599253BACKGROUND

Study Officials

  • Hanife Nuray Yılmaz, Associate Professor

    Marmara University Faculty of Dentistry Department of Orthodontics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 8, 2026

Study Start

April 21, 2025

Primary Completion

July 6, 2026

Study Completion

July 6, 2026

Last Updated

September 8, 2026

Record last verified: 2026-09

Locations

TU(1)